Advanced Solid Tumor Clinical Trial
Official title:
An Open, Multicenter Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the Combination of Puesta Mesylate for Injection in the Treatment of Advanced Solid Tumors
Primary Purpose Phase Ib Evaluate the safety and tolerability of the combination of puesta mesylate in the treatment of advanced solid tumors; and explore the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of the combination of puesta mesylate in patients with advanced solid tumors; Determine the recommended phase II dose (RP2D) for the combination of puesta mesylate in the treatment of advanced solid tumors. Phase IIa. To further evaluate the preliminary efficacy of the combination of puesta mesylate in patients with advanced solid tumors. Secondary objective Phase Ib Evaluate the safety and tolerability of poystat mesylate monotherapy in advanced solid tumors; To evaluate the preliminary efficacy of the combination of poystat mesylate in patients with advanced solid tumors; To evaluate the pharmacokinetic profile of the combination of puesta mesylate in the treatment of advanced solid tumors. Phase IIa To further evaluate the safety and tolerability of the combination of puesta mesylate in the treatment of advanced solid tumors; To evaluate the pharmacokinetic profile of the combination of puesta mesylate in the treatment of advanced solid tumors. Exploratory Objective. To evaluate the pharmacodynamic significance of biomarkers in the combination of puesta mesylate for the treatment of advanced solid tumors.
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